BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices

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BS EN 62366-1:2015

Medical devices. Application of usability engineering to medical devices

Status : Current   Published : June 2015



BS EN 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices

Many medical devices are non-intuitive and difficult to use because they have been developed without attention to human factors. This is a growing cause for concern because less skilled users, including patients, are now using medical devices more often – and the devices are becoming more complicated.

So BS EN 62366-1 sets out a usability engineering process for medical devices, to aid in designing user interfaces that are straightforward and efficient.

Previously, usability engineering for medical devices was covered in BS EN 62366:2008, but now that document has been fully revised into two parts:

  • Part 1, now published, contains updated normative requirements for the application of usability engineering to medical devices. 
  • Part 2,  a technical  report currently in preparation, will contain guidance, with a broader focus not only on safety but also on how usability relates to accuracy, completeness, efficiency and user satisfaction.  

This reduces the size of the normative standard and allows the guidance document to be updated more frequently to keep pace with the state of the art in usability engineering.

BS EN 62366-1 will be essential reading for manufacturers of medical equipment and systems, helping you to minimise user errors and so reduce risks.

(Kindly note that this standard supersedes a recently published amendment, BS EN 62366:2008+A1:2015.)

Standard NumberBS EN 62366-1:2015
TitleMedical devices. Application of usability engineering to medical devices
Publication Date30 June 2015
Cross ReferencesISO 14971:2007, EN ISO 14971:2012, IEC 60601-1:2005, EN 60601-1:2006, IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC 60601-1-6:2010, EN 60601-1-6:2010, IEC 60601-1-6:2010/A1:2013, EN 60601-1-6:2010/A1:2013, IEC 60601-1-8:2006, EN 60601-1-8:2007, IEC 60601-1-8:2006/A1:2012, EN 60601-1-8:2007/A1:2013, IEC 60601-1-11, EN 60601-1-11, ISO 7010:2011, EN ISO 7010:2012, ISO 9000:2005, EN ISO 9000:2005, ISO 9001:2008, EN ISO 9001:2008, ISO 9241-11:1998, EN ISO 9241-11:1998, ISO 13485:2003, EN ISO 13485:2012, IEC TR 61258:2008, ISO/IEC Guide 63:2012, ISO/TR 16142:2006, ANSI/AAMI HE 48:1993, ANSI/AAMI HE 74:2001, ANSI/AAMI HE 75:2009, EN 1041:2008, EN 1041:2008+A1:2013, GHTF SG2N31R8:2003
ReplacesBS EN 62366:2008+A1:2015
International RelationshipsEN 62366-1 Corr 1 (12/15)
Amended ByCorrigendum, January 2016
DescriptorsMedical equipment, Medical technology, Instructions for use, Medical instruments, Design, Equipment safety, Hazards, Ergonomics
Title in FrenchDispositifs médicaux. Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
Title in GermanMedizinprodukte. Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
ISBN978 0 580 91868 1
File Size2.991 MB

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